However fantastic your medical device or combination product, it will not get to market without appropriate evidence of your Human Factors work. Human Factors is now a regulatory requirement.
We conduct all our research according to the relevant ethical guidelines such as the MRS and BHBIA and when appropriate seek ethical approval.
We help you evidence your Human Factors work and support your regulatory submissions either as discrete tasks or full project support.
Example support includes:
- Task Analysis to understand all the discrete steps a user will take to interact with a device
- Comparative Threshold Analyses to identify whether any differences exist between a drug product already on the market and a new, similar drug product, instead of Human Factors testing
- Usability Risk Assessments to assess how a user’s perception, cognition and action is affected at each discrete task to identify foreseeable misuse scenarios.
- Identification of critical tasks for validation testing
- Support creating usability engineering file for regulatory submission
- Carrying out research on identification of known use issues
All our work is compliant and mindful of the relevant standards and guidelines including: